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Belrapzo Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Multi-dose vial (4mL)—1
Manufacturer
Generic Availability
NO
Mechanism of Action
Bendamustine forms covalent bonds with electron-rich nucleophilic moieties, resulting in interstrand DNA crosslinks. The bifunctional covalent linkage can lead to cell death via several pathways. Bendamustine is active against both quiescent and dividing cells. However, the exact mechanism of action remains unknown.
Belrapzo Indications
Indications
Chronic lymphocytic leukemia (CLL). Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within 6 months of treatment with rituximab or a rituximab–containing regimen.
Belrapzo Dosage and Administration
Adult
CLL: Give by IV infusion over 30mins. 100mg/m2 on Days 1 and 2 of a 28-day cycle, up to 6 cycles. Hematologic toxicity (≥Grade 3): reduce dose to 50mg/m2 on Days 1 and 2 of each cycle; if toxicity recurs, reduce dose to 25mg/m2 on Days 1 and 2. Non-hematologic toxicity (clinically significant ≥Grade 3): reduce dose to 50mg/m2 on Days 1 and 2 of each cycle. Subsequent cycles: may consider dose re-escalation. NHL: Give by IV infusion over 60mins. 120mg/m2 on Days 1 and 2 of a 21-day cycle, up to 8 cycles. Hematologic toxicity (Grade 4) or non-hematologic toxicity (≥Grade 3): reduce dose to 90mg/m2 on Days 1 and 2 of each cycle; if toxicity recurs, reduce dose to 60mg/m2 on Days 1 and 2. Delay treatment for Grade 4 hematologic toxicity or clinically significant ≥Grade 2 non-hematologic toxicity.
Children
Not established.
Belrapzo Contraindications
Not Applicable
Belrapzo Boxed Warnings
Not Applicable
Belrapzo Warnings/Precautions
Warnings/Precautions
Myelosuppression; monitor CBCs including leukocytes, platelets, hemoglobin, neutrophils frequently; restart treatment based on ANC and platelet count recovery. Monitor for signs of infection or reactivation of infections (eg, hepatitis B, CMV, tuberculosis, herpes zoster); prophylaxis and treat prior to therapy if occur. Withhold dose and evaluate if progressive multifocal leukoencephalopathy (PML) is suspected. Consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressives if PML develops. Monitor for infusion or skin reactions (may be fatal), tumor lysis syndrome, secondary malignancies. Monitor LFTs prior to and during therapy. Renal impairment (CrCl <30mL/min): not recommended. Hepatic impairment (total bilirubin 1.5–3×ULN and AST or ALT 2.5–10×ULN, or total bilirubin >3×ULN): not recommended. Avoid extravasation. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) or for 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Belrapzo Pharmacokinetics
Distribution
Volume of distribution (at steady state): ~20–25 L. Plasma protein bound: 94–96%.
Elimination
Renal (~50%), fecal (~25%). Half-life: ~40 minutes. Clearance: ~700mL/min.
Belrapzo Interactions
Interactions
May be potentiated by CYP1A2 inhibitors or antagonized by CYP1A2 inducers; if needed, consider alternatives.
Belrapzo Adverse Reactions
Adverse Reactions
Lymphopenia, anemia, leukopenia, thrombocytopenia, neutropenia, pyrexia, nausea, vomiting, fatigue, diarrhea, constipation, anorexia, cough, headache, weight loss, dyspnea, rash, stomatitis; infection, infusion reactions (discontinue if severe), PML, tumor lysis syndrome, skin reactions (if severe or progressive, withhold dose or discontinue), hepatotoxicity, other malignancies (eg, myelodysplastic syndrome, acute myeloid leukemia, bronchial carcinoma).
Belrapzo Clinical Trials
See Literature
Belrapzo Note
Not Applicable
Belrapzo Patient Counseling
See Literature
